SAFETY
MEASURES MUST BE TAKEN: GLOVES MUST BE WORN; SMOKING, EATING, DRINKING,
APPLICATION OF COSMETICS, AND MANIPULATION OF CONTACT LENSES ARE PROHIBITED
IN ALL TECHNICAL WORK AREAS.REFER TO
THE UNIVERSAL PRECAUTIONS POLICIES.

CLIA
Complexity: Waived

I.
Method

Clinitest
is a reagent tablet based on the Benedict's copper reduction reaction, combining reactive ingredients with an
integral heat generating system. The test is used to determine the amount of
reducing substances (generally glucose) in urine. Clinitest provides clinically
useful information on carbohydrate metabolism. The standard (5-Drop) procedure
measures up to 2%sugar; when measurement up to 5% is desired, the 2-Drop method
should be used.

II.Principle

Copper
sulfate in Clinitest reacts with reducing substances in urine converting cupric
sulfate to cuprous oxide. The resultant color, which varies with the amount of
reducing substances present, ranges from blue through green to orange. Sodium hydroxide provides the alkaline medium
necessary for the reaction. The required heat is provided by the reaction of
sodium hydroxide with water and with citric acid.

III.Specimen Collection and Preparation

Prior
to collecting the patient’s sample, the patient’s identity must be verified by
looking at the arm band. Fresh urine should be used since glucose and other
reducing sugars are consumed by bacteria. Refrigerate urine specimens if they
cannot be used immediately. Preservatives are not recommended.

Clinitest
tablets are stable for long periods when stored at room temperature in unopened
bottle. (Miles Inc. does specify expiration date on each bottle). The tablets
are very hygroscopic, and cautions should be taken to avoid exposure to
moisture. Label bottles with date opened.

V.Procedure

A. 5-Drop Method

1.Collect urine in clean container. With
dropper in upright position, place 5 drops of urine in test tube.Rinse dropper with water and add 10 drops of
distilled water to test tube.

2.Drop one Clinitest tablet into test tube.
Watch while complete boiling reaction takes place. Do not shake test tube
during boiling, or for the following 15 seconds after boiling has stopped.

3.At the end of this 15-second waiting
period, shake test tube gently to mix contents. Compare color of liquid to
Color Chart.Ignore sediment that may
for in the bottom of the test tube.Ignore changes after the 15-second waiting period.

4.Write down the percent (%) result which
appears on the color block that most closely matches the color of the liquid.

5.If result is 2% or more, perform the
2-drop method.

B. 2-Drop Method

1.Collect urine in a clean container. With
dropper in upright position, place 2 drops of urine in test tube. Rinse dropper
with water and add 10 drops of distilled water to test tube.

2.Drop one Clinitest tablet into test tube.
Watch while complete boiling reaction takes place. Do not shake test tube
during boiling, or for the following 15 seconds after boiling has stopped.

3.At the end of this 15-second waiting
period, shake test tube gently to mix contents. Compare color of liquid to
Color Chart.Ignore sediment that may
form in the bottom of the test tube.Ignore changes after the 15-second waiting period.

4.Write down the percent (%) result which
appears on the color block that most closely matches the color of the liquid.

Note: Urine
containing more than 2% sugar using the 5-drop method or more than 5% sugar
using the 2-drop method may cause a very rapid color change during the boiling
and 15-second waiting period. Observe the solution closely during this time to
detect "pass-through" color changes.Should these occur, the color will pass rapidly through bright orange to
a dark brown or greenish brown. In this case, report the result as over 2% sugar if using the 5-Drop Method or as
over 5% sugar if using the 2-Drop Method, and do not compare final color to
Color Chart.

VI.
Quality Control

A.Reagents

Quantimetrix Normal and Abnormal level.
Prepared from normal human urine to which is added predetermined amounts of
chemicals.Liquid, ready-to-use.

B.Storage and Stability

Stable until expiration date stated on
label, when stored between 2° and 8°C. Controls
may be stored at room temperature for up to one month.Label controls with date opened and room
temperature expiration date. DO NOT FREEZE.

C.Procedure

1.On initial use, remove the control from
the refrigerator and allow to reach room temperature prior to testing.

2.Remove cap and invert bottle, dispense
control into a test tube.

3.Wipe off dropper tips and recap controls.

4.Use urine control as you would patient
specimen, according to procedure above for the standard 5-Drop Method.

5.Record results on the Quality Control Log
Sheet.

D.Frequency

Two levels of quality control (normal
and abnormal) should be run every day of patient testing.Controls should also be run whenever a new
bottle of Clinitest tablets is opened.

E. Results

Expected values are listed on the
Quality Control Log sheet. If controls are not within acceptable limits the
following steps should be taken:

§The metabolites of some sulfa drugs and methapyriline
compounds may interfere with the sensitivity of Clinitest 2-Drop Method.These substances are not known to interfere
at glucose levels of 1/2% or higher.